Quality Manager

Senior Leadership Opportunity | Regulated Healthcare Manufacturing

An exciting opportunity has arisen for an experienced Quality Manager to lead the Quality function within a highly regulated healthcare manufacturing environment.

This is a strategic and hands‑on leadership role with full responsibility for the Quality Management System (QMS) across Manufacturing and Engineering. You will play a key role in driving compliance, operational excellence, customer satisfaction, and continuous improvement.

If you are looking for a position where you can truly influence quality culture, regulatory performance, and business success — this is an excellent next step.

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• Lead and continuously improve the Quality Management System in line with regulatory, customer, and business requirements.
  
• Act as Management Representative for the QMS.
  
• Provide Quality leadership across manufacturing operations and engineering activities.
  
• Ensure customer requirements are fully understood and delivered throughout the product lifecycle.
  
• Oversee and drive effective management of:
  
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  • Deviations & Non‑Conformances
    
  • CAPAs & SCARs
    
  • OOS Investigations
    
  • Complaints & Change Control
    
  • Document & Record Management
    
  
  
• Lead customer and regulatory audits with confidence and professionalism.
  
• Drive robust root cause analysis and sustainable corrective actions.
  
• Lead Management Review and provide clear quality performance reporting to senior leadership.
  
• Support new product introductions, technology transfers, and validation activities.
  
• Manage and develop the Quality team within agreed budgets.
  

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• Degree qualified in Engineering, Science, Quality, or a related discipline.
  
• Strong experience within medical device, pharmaceutical, or regulated healthcare manufacturing.
  
• Excellent working knowledge of ISO standards, FDA requirements, and regulated QMS frameworks.
  
• Qualified Quality Auditor.
  
• Proven leadership capability with the ability to influence across all levels of the organisation.
  
• Strong problem‑solving skills, with practical application of Lean, Six Sigma, and statistical tools. xcfaprz
  
• Commercially aware, proactive, and solutions‑focused.